BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOCHEK PLUS ANALYZER

    MDR report key: 22213936 · Received June 16, 2025

    Report

    Report Number
    1836135-2025-00009
    Event Type
    Malfunction
    Date Received
    June 16, 2025
    Date of Event
    February 24, 2025
    Report Date
    June 16, 2025
    Manufacturer
    PTS DIAGNOSTICS
    Product Code
    CGA
    UDI-DI
    00382932700016
    PMA / PMN Number
    K140068
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON VISUAL INSPECTION OF THE BATTERY COMPARTMENT, PLASTIC CASE DAMAGE INDICATIVE OF IMPROPER/FORCEFUL REMOVAL OF THE BATTERIES WITH A FOREIGN OBJECT WAS OBSERVED. PTS IS CONFIDENT THAT THIS DAMAGE OCCURRED POST-DISTRIBUTION, AS THERE ARE NO MANUFACTURING STEPS THAT WOULD CAUSE THIS TYPE OF DAMAGE. THE CUSTOMER ALLEGATION OF OVERHEATING WAS NOT OBSERVED ON THE RETURNED ANALYZER. NUMEROUS BATTERY COMPARTMENT IMPROVEMENTS HAVE ALREADY BEEN IMPLEMENTED PRIOR TO THESE ALLEGATIONS FROM THE FIELD. PROCESS IMPROVEMENTS AND PART SPECIFICATIONS HAVE ENHANCED SEATING AND HOLD CAPACITY OF THE BATTERY CONTACTS. ADDITIONALLY, A NEW BATTERY COMPARTMENT DESIGN (APPROVED BY THE FDA PER K193406) ELIMINATES THE POTENTIAL FOR OVERHEATING BY REMOVING THE POINT OF CONTACT THAT AN UNSEATED TERMINAL WOULD REACH.

    Description of Event or Problem · 0

    THE CONTACT REPORTED THAT THEIR ANALYZER GOT WARM UPON BATTERY INSTALLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040302 CARDIOCHEK PLUS ANALYZER CLINICAL CHEMISTRY ANALYZER CGA PTS DIAGNOSTICS 1.11 00382932700016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown